CANTEX 200MG FILM COATED TABLETS

Valsts: Kipra

Valoda: grieķu

Klimata pārmaiņas: Φαρμακευτικών Υπηρεσιών του Υπουργείου Υγείας

Aktīvā sastāvdaļa:

VORICONAZOLE

Pieejams no:

DELORBIS PHARMACEUTICALS LTD (0000009620) 17 ATHINON STREET, ERGATES INDUSTRIAL AREA, LEFKOSIA, 2081, 28629

ATĶ kods:

J02AC03

SNN (starptautisko nepatentēto nosaukumu):

VORICONAZOLE

Deva:

200MG

Zāļu forma:

FILM COATED TABLETS

Kompozīcija:

VORICONAZOLE (8000002580) 200.000000000000MG

Ievadīšanas:

ORAL USE

Receptes veids:

Εθνική Διαδικασία

Ārstniecības joma:

VORICONAZOLE

Produktu pārskats:

Νομικό καθεστώς: Με Ιατρική Συνταγή; PACK WITH 2 TABS IN BLISTER(S) (320018801) 2.00 TABLET - Εγκεκριμένο - Με Ιατρική Συνταγή; PACK WITH 10 TABS IN BLISTER(S) (320018802) 10.00 TABLET - Εγκεκριμένο - Με Ιατρική Συνταγή; PACK WITH 14 TABS IN BLISTER(S) (320018803) 14.00 TABLET - Εγκεκριμένο - Με Ιατρική Συνταγή; PACK WITH 20 TABS IN BLISTER(S) (320018804) 20.00 TABLET - Εγκεκριμένο - Με Ιατρική Συνταγή; PACK WITH 28 TABS IN BLISTER(S) (320018805) 28.00 TABLET - Εγκεκριμένο - Με Ιατρική Συνταγή; PACK WITH 30 TABS IN BLISTER(S) (320018806) 30.00 TABLET - Εγκεκριμένο - Με Ιατρική Συνταγή; PACK WITH 50 TABS IN BLISTER(S) (320018807) 50.00 TABLET - Εγκεκριμένο - Με Ιατρική Συνταγή; PACK WITH 56 TABS IN BLISTER(S) (320018808) 56.00 TABLET - Εγκεκριμένο - Με Ιατρική Συνταγή; PACK WITH 100 TABS IN BLISTER(S) (320018809) 100.00 TABLET - Εγκεκριμένο - Με Ιατρική Συνταγή

Lietošanas instrukcija

COMPARATIVE TABLE ENGLISH VS GREEK PIL
PACKAGE LEAFLET: INFORMATION FOR THE USER
CANTEX 50 MG FILM-COATED TABLETS
CANTEX 200 MG FILM-COATED TABLETS
voriconazole
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE
BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor, pharmacist or
nurse.

This medicine has been prescribed for you only. Do not pass it on to
others.
It may harm them, even if their signs of illness are the same as
yours.

If you get any side effects, talk to your doctor, pharmacist or nurse.
This
includes any possible side effects not listed in this leaflet. See
section 4.
WHAT IS IN THIS LEAFLET
1.
What Cantex is and what it is used for
2.
What you need to know before you take Cantex
3.
How to take Cantex
4.
Possible side effects
5.
How to store Cantex
6.
Contents of the pack and other information
1. WHAT CANTEX IS AND WHAT IT IS USED FOR
Cantex contains the active substance voriconazole. Cantex is an
antifungal
ΦΎΛΛΟ ΟΔΗΓΙΏΝ ΧΡΉΣΗΣ: ΠΛΗΡΟΦΟΡΊΕΣ ΓΙΑ
ΤΟΝ ΧΡΉΣΤΗ
CANTEX 50 MG ΕΠΙΚΑΛΥΜΜΈΝΑ ΜΕ ΛΕΠΤΌ ΥΜΈΝΙΟ
ΔΙΣΚΊΑ
CANTEX 200 MG ΕΠΙΚΑΛΥΜΜΈΝΑ ΜΕ ΛΕΠΤΌ ΥΜΈΝΙΟ
ΔΙΣΚΊΑ
βορικοναζόλη
ΔΙΑΒΆΣΤΕ ΠΡΟΣΕΚΤΙΚΆ ΟΛΌΚΛΗΡΟ ΤΟ ΦΎΛΛΟ
ΟΔΗΓΙΏΝ ΧΡΉΣΗΣ ΠΡΙΝ ΑΡΧΊΣΕΤΕ
ΝΑ
ΠΑΊΡΝΕΤΕ
ΑΥΤΌ
ΤΟ
ΦΆΡΜΑΚΟ,
ΔΙΌΤΙ
ΠΕΡΙΛΑΜΒΆΝΕΙ
ΣΗΜΑΝΤΙΚΈΣ
ΠΛΗΡΟΦΟΡΊΕΣ ΓΙΑ ΣΑΣ.

Φυλάξτε αυτό το φύλλο οδηγιών χρήσης.
Ίσως χρειαστεί να το διαβάσετε
ξανά.

Εάν έχετε περαιτέρω απορίες, ρωτήστε
τον γιατρό, τον φαρμακοποιό ή τον
νοσοκόμο σας.

Η συνταγή για αυτό το φάρμακο
χορηγήθηκε αποκλειστικά για σας. Δεν
π

Produkta apraksts

1.
NAME OF THE MEDICINAL PRODUCT
Cantex 50 mg Film-coated tablets
Cantex 200 mg Film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 50 or 200 mg voriconazole.
Excipient(s) with known effect
Cantex 50 mg film-coated tablets
Each film-coated tablet contains 66.0 mg lactose monohydrate.
Cantex 200 mg film-coated tablets
Each film-coated tablet contains 264.0 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Cantex 50 mg film-coated tablets
White to off-white, round film-coated tablets.
Cantex 200 mg film-coated tablets
White to off-white, capsule-shaped film-coated tablets.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Cantex is a broad spectrum, triazole antifungal agent and is indicated
in adults and children aged
2 years and above as follows:
Treatment of invasive aspergillosis.
Treatment of candidaemia in non-neutropenic patients.
Treatment of fluconazole-resistant serious invasive _Candida_
infections (including _C. krusei_).
Treatment of serious fungal infections caused by _Scedosporium _spp.
and _Fusarium _spp_._
1
SUMMARY OF PRODUCT CHARACTERISTICS
Cantex should be administered primarily to patients with progressive,
possibly life-threatening
infections.
Prophylaxis of invasive fungal infections in high risk allogeneic
hepatopoietic stem cell transplant
(HSCT) recipients.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Electrolyte disturbances such as hypokalaemia, hypomagnesaemia and
hypocalcaemia should be
monitored and corrected, if necessary, prior to initiation and during
voriconazole therapy (see
section 4.4).
Treatment
_Adults_
Therapy must be initiated with the specified loading dose regimen of
either intravenous or oral
voriconazole to achieve plasma concentrations on Day 1 that are close
to steady state. On the
basis of the high oral bioavailability (96 %; see section 5.2),
switching between intravenous and
oral administration is appropriate when clinically indicated.
Detailed information on dosage